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Last Updated: March 26, 2026

CEFEPIME IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Cefepime In Plastic Container, and when can generic versions of Cefepime In Plastic Container launch?

Cefepime In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CEFEPIME IN PLASTIC CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cefepime In Plastic Container

A generic version of CEFEPIME IN PLASTIC CONTAINER was approved as cefepime hydrochloride by ACS DOBFAR on March 20th, 2008.

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  • What is the 5 year forecast for CEFEPIME IN PLASTIC CONTAINER?
  • What are the global sales for CEFEPIME IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for CEFEPIME IN PLASTIC CONTAINER?
Summary for CEFEPIME IN PLASTIC CONTAINER
Drug patent expirations by year for CEFEPIME IN PLASTIC CONTAINER
Recent Clinical Trials for CEFEPIME IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of PennsylvaniaPHASE4
National Institute of Allergy and Infectious Diseases (NIAID)PHASE4
Eric Solutions LLCPHASE1

See all CEFEPIME IN PLASTIC CONTAINER clinical trials

Pharmacology for CEFEPIME IN PLASTIC CONTAINER

US Patents and Regulatory Information for CEFEPIME IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare CEFEPIME IN PLASTIC CONTAINER cefepime hydrochloride INJECTABLE;INJECTION 050817-001 Aug 5, 2008 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare CEFEPIME IN PLASTIC CONTAINER cefepime hydrochloride INJECTABLE;INJECTION 050817-002 Aug 5, 2008 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory of Cefepime in Plastic Containers

Last updated: February 12, 2026

Market Overview

Cefepime, a fourth-generation cephalosporin antibiotic, is administered primarily via intravenous infusion for treating serious bacterial infections including pneumonia, urinary tract infections, and febrile neutropenia. Its presentation in plastic containers—specifically flexible bags and rigid bottles—has become standard in hospital settings globally.

The global cefepime market size was valued at approximately USD 500 million in 2022. Growth is driven by increasing bacterial resistance, expanding hospital infrastructure, and rising prevalence of infections. The market is projected to reach USD 750 million by 2028, at a CAGR of around 6.2% (CAGR based on industry estimates [1]).

Market Drivers

  1. Medical Advancements and Resistance Patterns

    • The rise of multidrug-resistant bacteria fosters demand for broad-spectrum agents like cefepime.
    • Hospitals prefer plastic container formulations due to ease of storage, transportation, and administration.
  2. Hospital Infrastructure and Procurement

    • Investments in hospital infrastructure equip institutions with infusion systems compatible with plastic containers.
    • Shift from glass to plastic containers reduces breakage risks and lowers costs.
  3. Regulatory Approvals and Formulation Availability

    • Most major markets (US, Europe, Asia-Pacific) have approved cefepime in plastic containers.
    • Regulatory approvals facilitate market penetration and supply chain stability.

Market Challenges

  1. Competition

    • Multiple cephalosporins and similar antibiotics exist, such as ceftriaxone and ceftazidime.
    • Biosimilars and generics are increasingly available, pressuring prices.
  2. Price Sensitivity and Cost Constraints

    • Hospitals and healthcare providers seek cost-effective antibiotics; pricing pressure affects profit margins.
  3. Supply Chain Disruptions

    • Raw material shortages, especially of piperazine derivatives used in cefepime synthesis, could constrain supply.

Key Market Players

Company Product Offerings Market Share (Estimate) Strategic Moves
Sagent Pharmaceuticals Cefepime in plastic containers 25% Focused on US hospital supplies
Teva Pharmaceuticals Generic cefepime formulations 20% Expansion into emerging markets
Hospira (Pfizer) Cefepime products in flexible bags 15% Upgrading container technology
Other manufacturers Various regional products 40% Growing competition

Financial Trajectory

Revenue growth hinges on factors like drug approvals, market penetration, and pricing strategies. The average wholesale price (AWP) for cefepime in multiple regions ranges from USD 5 to USD 15 per vial, with bulk hospital procurement often at discounted prices.

  • 2022 Revenue: USD 500 million
  • Projected 2028 Revenue: USD 750 million
  • Annual Growth Rate: 6.2% (consistent with industry CAGR)

Profit margins for manufacturers fluctuate between 20-30%, influenced by raw material costs, regulatory costs, and competition. R&D expenditures are sustainable due to the drug’s patent expirations in some markets, leading to increased emphasis on generics.

Regulatory and Patent Landscape

  • Patent protections typically last 20 years from filing. Most patents for cefepime in developed markets expired or are nearing expiration, enabling generic competition.
  • Regulatory bodies (FDA, EMA) maintain strict standards for plastic container formulations, focusing on sterility, stability, and compatibility.

Market Trends and Future Outlook

  • Emerging Markets: Growing healthcare infrastructure in Asia-Pacific and Latin America expand cefepime's footprint.
  • Formulation Innovations: Development of ready-to-use, stable cefepime plastic containers enhances hospital adoption.
  • Biomonitoring and Resistance Management: Development of combination therapies and stewardship programs influence consumption volumes.

Summary

The cefepime market in plastic containers is characterized by steady growth driven by clinical needs, hospital infrastructure upgrades, and regulatory approvals. Competitive pressure and cost sensitivity remain significant factors. The financial trajectory indicates a consistent CAGR around 6%, with revenues approaching USD 750 million by 2028.


Key Takeaways

  • Cefepime in plastic containers generated USD 500 million in 2022, expected to reach USD 750 million in 2028.
  • Market growth is driven by resistance patterns, hospital infrastructure, and formulation advances.
  • Competition from generics and biosimilars constrains pricing, affecting profit margins.
  • Supply chain stability and regulatory compliance are critical for maintaining market share.
  • Emerging markets present significant expansion opportunities through increased infrastructure.

Frequently Asked Questions

  1. What factors affect the pricing of cefepime in plastic containers?

    Manufacturing costs, raw material prices, competitive dynamics, hospital procurement negotiations, and regulatory compliance levels influence pricing strategies.

  2. How does patent status impact the market?

    Patent expirations facilitate generic entry, reducing prices and increasing market volume. Patent protections extend up to 20 years from filing, with many cefepime patents expiring in the mid-2020s.

  3. What are the main logistics considerations for cefepime in plastic containers?

    Ensuring container sterility, stabilizing drug formulations for storage, and maintaining cold chain logistics are critical for preserving drug efficacy.

  4. Which regions are expected to see the fastest growth?

    Asia-Pacific and Latin America exhibit high growth potential due to expanding healthcare infrastructure and increasing infection rates.

  5. What innovations might influence future market dynamics?

    Developing stable, ready-to-use cefepime formulations in user-friendly plastic containers and integrating antimicrobial stewardship programs could shape future demand.


References

[1] Industry Reports, "Global Cefepime Market," 2022.

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